{"entity":{"id":"donafenib","kind":"drug","name":"Donafenib","aka":[],"tldr":"Donafenib is a Chinese redesign of sorafenib that lived longer than the original in a head-to-head liver cancer trial and is approved in China as a first-line option.","summary":"Zelgen's donafenib was approved by the NMPA in June 2021 for first-line unresectable hepatocellular carcinoma on the ZGDH3 trial (668 patients: median overall survival 12.1 versus 10.3 months with sorafenib, hazard ratio 0.83; Journal of Clinical Oncology 2021), the first drug to beat sorafenib on survival in this setting. Radioiodine-refractory differentiated thyroid cancer followed in 2022. A modest gain, but a first for a Chinese company and a model of incremental chemistry (deuteration) turned into an approval.","status":"approved","asOf":"2026-09-10","wikipedia":"https://en.wikipedia.org/wiki/Donafenib","links":[{"label":"Suzhou Zelgen Biopharmaceuticals","url":"https://www.zelgen.com/en/"},{"label":"ZGDH3 (J Clin Oncol 2021)","url":"https://doi.org/10.1200/JCO.20.02672"},{"label":"NMPA (National Medical Products Administration)","url":"https://www.nmpa.gov.cn"}],"tags":["china"],"related":[],"cancers":["hcc","thyroid"],"sections":[],"technologies":["kinase-inhibitors","antiangiogenic"],"targets":["vegf","braf"],"drugs":[],"companies":["zelgen"],"institutions":[],"pathways":["vegf-angiogenesis","ras-mapk"],"terms":[],"trials":["zgdh3"],"people":[],"bottlenecks":[],"keyPapers":["paper-gordan-j-clin-oncol"],"journals":[],"dependsOn":[],"notes":[],"brand":"Zepsun","code":"CM4307","modality":"Small-molecule multi-kinase inhibitor (deuterated sorafenib)","mechanism":"Deuterium-substituted analogue of sorafenib inhibiting RAF kinases and VEGFR/PDGFR; deuteration slows metabolism and raises exposure.","approvals":[{"region":"China","year":2021,"indication":"First-line unresectable hepatocellular carcinoma (ZGDH3)"},{"region":"China","year":2022,"indication":"Radioiodine-refractory differentiated thyroid cancer"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/donafenib/","neighbours":{"cancer":[{"id":"hcc","kind":"cancer","name":"Hepatocellular carcinoma","route":"/cancers/hcc/"},{"id":"thyroid","kind":"cancer","name":"Thyroid cancer","route":"/cancers/thyroid/"}],"technology":[{"id":"antiangiogenic","kind":"technology","name":"Anti-angiogenic therapy","route":"/technologies/antiangiogenic/"},{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"target":[{"id":"braf","kind":"target","name":"BRAF","route":"/targets/braf/"},{"id":"vegf","kind":"target","name":"VEGF / VEGFR","route":"/targets/vegf/"}],"company":[{"id":"zelgen","kind":"company","name":"Suzhou Zelgen Biopharmaceuticals","route":"/companies/zelgen/"}],"pathway":[{"id":"hepatocellular-carcinoma-signalling","kind":"pathway","name":"Hepatocellular carcinoma (KEGG map)","route":"/pathways/hepatocellular-carcinoma-signalling/"},{"id":"ras-mapk","kind":"pathway","name":"RAS / RAF / MEK / ERK (MAPK)","route":"/pathways/ras-mapk/"},{"id":"vegf-angiogenesis","kind":"pathway","name":"VEGF angiogenesis","route":"/pathways/vegf-angiogenesis/"}],"trial":[{"id":"zgdh3","kind":"trial","name":"ZGDH3 (donafenib vs sorafenib)","route":"/trials/zgdh3/"}],"paper":[{"id":"paper-gordan-j-clin-oncol","kind":"paper","name":"Systemic Therapy for Advanced Hepatocellular Carcinoma: ASCO Guideline","route":"/key-papers/paper-gordan-j-clin-oncol/"}],"person":[{"id":"qin-shukui","kind":"person","name":"Shukui Qin","route":"/people/qin-shukui/"}]}}